Concomitant Bedside Percutaneous Tracheostomy and Ultrasound Gastrostomy (TPUG)

A Multicenter, Randomized Controlled Trial of Concomitant Bedside Percutaneous Tracheostomy and Ultrasound Gastrostomy

The goal of this research study is to assess the FDA approved technique for inserting a feeding tube (gastrostomy) along with a breathing tube (tracheostomy) for patients that cannot breathe or eat on their own in the ICU (Intensive Care Unit). All subjects in the study will receive a tracheostomy, but each patient will be randomly assigned a common method for gastrostomy placement. The placement of the tube and tracheostomy will occur as part of normal clinical practice. Researchers will compare subjects in the control group and the intervention group to evaluate the benefits of performing a tracheostomy and gastrostomy tube at the same time. Researchers will also evaluate the likelihood of the PUG procedure decreasing a patient's length of stay in the ICU.

Study Overview

• Status: Not yet recruiting
• Conditions: Respiratory Failure; Gastrostomy; Ventilatory Failure
• Intervention / Treatment: Procedure: PEG; Procedure: PRG; Device: TPUG

Detailed Description

The research team will assess eligibility during the screening period for percutaneous tracheostomy and gastrostomy. Once eligibility is assessed, participants and/or their legally authorized representative (LAR) will be approached for consent and enrollment into the trial. Randomization occurs at the time of the subject's enrollment, and participants will be randomized to either the Control or Intervention (TPUG) groups using randomly assigned numbers. The study team will also be blinded to the assigned group prior to recruitment to limit selection bias. The intervention group will receive concomitant placement of the tracheostomy and PUG, which will be performed using the FDA-cleared device for ultrasound gastrostomy, the PUMA-G System. The control group will receive percutaneous bedside tracheostomy along with gastrostomy methods other than PUG. Each site will perform the procedures of tracheostomy and gastrostomy using the devices according to their institutional policy and guidelines. Investigators will utilize case report forms (CRFs) and chart review to collect demographic information, important medical events, illnesses, and laboratory data needed for outcomes assessment.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Richard Gentry Wilkerson, M.D.; Phone Number: 410-328-4237; Email: gwilkerson@som.umaryland.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Medical Systems

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Informed consent must be obtained from the participant or a Legally Authorized Representative before any trial-specific assessment is performed
• Male or female ≥ 18 years of age
• Participants with Ventilator Dependent Respiratory Failure (VDRF)
• Indication for a bedside percutaneous tracheostomy procedure using an FDA approved percutaneous dilatational tracheostomy device
• Indication for percutaneous gastrostomy including Percutaneous Ultrasound (PUG), Percutaneous Radiologic (PRG), and Percutaneous Endoscopic Gastrostomy (PEG) using an FDA approved gastrostomy kit
• No contraindications to bedside percutaneous tracheostomy OR gastrostomy
• Women of childbearing potential must have negative serum or urine pregnancy test during the current hospitalization

Exclusion Criteria:

• History of prior gastrostomy, tracheostomy, laryngectomy, gastrostomy prior to tracheostomy decision, known head and neck and gastrointestinal abnormality (cancer, congenital abnormality, anatomic variants).
• Hospitalization > 21 days at the time of screening
• Known social discharge issues that in the opinion of the investigator will substantially impact the LOS.
• Participants with non-survivable injuries or disease, anticipated life expectancy < 30 days.
• Uncontrolled coagulopathy
• Contraindications for percutaneous gastrostomy procedures
• Severe Ascites
• Abdominal wall infection at selected site of procedure
• Severe gastroparesis
• Gastric outlet obstruction
• Absolute contraindications to percutaneous dilatational tracheostomy procedure
• Cervical instability
• Infection at the planned insertion site
• Relative contraindications to percutaneous dilatational tracheostomy deemed present by the clinical team
• Difficult anatomy (e.g., short neck, morbid obesity, minimal next extension, or tracheal deviation)
• Severe respiratory disease resulting in inability to withstand periods of apnea or in the loss of positive pressure ventilation
• Pregnancy
• Incongruent goals of care between care team and LAR (family representative).
• Other procedure related concerns by the primary team that would affect safety of the patient.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control Group; The control group will receive percutaneous bedside tracheostomy along with gastrostomy methods other than PUG, including but not limited to Percutaneous Endoscopic or Radiologic Gastrostomy (PEG or PRG, respectively), or surgical gastrostomy.	Procedure: PEG; Each site will perform the procedures of gastrostomy placement using the devices according to their institutional policy and guidelines.; Other Names: Percutaneous Endoscopic Gastrostomy; Procedure: PRG; Each site will perform the procedures of gastrostomy placement using the devices according to their institutional policy and guidelines.; Other Names: Percutaneous Radiographic Gastrostomy
Experimental: Intervention Group (TPUG); The intervention group will receive concomitant percutaneous bedside tracheostomy and PUG.	Device: TPUG; Tracheostomy shall utilize any FDA approved device for the performance of percutaneous dilatational tracheostomy. PUG shall be performed using the only FDA-cleared device for ultrasound gastrostomy, the PUMA-G System.; Other Names: Percutaneous Tracheostomy and Percutaneous Ultrasound Gastrostomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay in ICU	To compare the ICU (Intensive Care Unit) length of stay (days) from the time the decision is made to place a tracheostomy tube and gastrostomy tube to the time of discharge from the ICU for participants receiving TPUG versus a control group.	ICU discharge - up to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay	To compare the hospital length of stay (days) and total hospital costs (United States Dollars) from the time the decision is made to place a tracheostomy tube and gastrostomy tube to the time of discharge from the hospital for participants receiving TPUG versus a control group.	Hospital discharge - through study completion, an average of 45 days
Demographics	To assess confounding variables and differences between groups that could affect outcomes: Age (categorized as <50 yrs., 51-70 yrs., >70 yrs); Gender (Assigned at birth); Race (Self-Reported); Insurance (categorized as Insured versus Uninsured); Covid status (categorized as Positive, Negative, Indeterminate); Primary diagnosis; Primary ICU type; Charlson Score; SAPS Score	End of study comparison - through study completion, an average of 45 days

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Investigators: Study Chair: Dana Beach, RN, University of Maryland, Baltimore

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: June 28, 2023
• First Submitted That Met QC Criteria: July 12, 2023
• First Posted (Actual): July 21, 2023

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Tracheostomy; PEG; Gastrostomy; Percutaneous Endoscopic Gastrostomy; Ventilator Dependent Respiratory Failure; Tracheostomy and Percutaneous Ultrasound Gastrostomy (TPUG); Percutaneous Radiologic Gastrostomy (PRG)
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Respiratory Insufficiency; Hypoventilation
• Other Study ID Numbers: HP-00104764

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

The Principal Investigator will centrally aggregate and maintain screening and recruitment information from all study sites and routinely inform and share this data with the entire study team in a deidentified fashion. The principal investigator and co-investigators will maintain a personal participant identification list (participant numbers with the corresponding participant names) to enable records to be identified.

The University of Maryland School of Medicine's research team will ensure that all study-related documents are collected and maintained.

• IPD Sharing Time Frame: Until the end of the study. Essential documents will be retained for at least 2 years.
• IPD Sharing Access Criteria: All study team members will attend online trainings to receive instruction on the protocol, consent process and associated regulatory requirements for the conduct of Clinical Trials/Human Subjects Research. All persons assisting with the trial are adequately informed about the protocol, any amendments to the protocol, any changes to the informed consent form, the trial treatments, eligibility criteria and their trial related duties and functions.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No